Spice II Plus: Acute toxicity of new synthetic cannabinoids and stimulant drugs
Organizational Data
- DRKS-ID:
- DRKS00005093
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2013-07-24
- Last update in DRKS:
- 2023-06-02
- Registration type:
- Prospective
Acronym/abbreviation of the study
Spice II Plus
URL of the study
No Entry
Brief summary in lay language
Since 2008, there has been an increase in the consumption of designer drugs. Two thirds of the substances that were newly recorded by the european early warning system were synthetic cannabinoids and synthetic cathinones. Whereas in the past many of this substances were placed under illicit-drugs-laws (lastly in July 2012), some new substances have still no legal regulation. These seemingly harmless products may nevertheless lead to unexpected psychic and physical disorder causing the 'user' to seek emergency treatment. In order to associate the reported symptoms to the consumed substances, an analytical verification of the uptake is required. Trial objective: To find out which new drugs lead to consultation of emergency units because of undesirable effects. To correlate symptoms and outcome to the substances found in the toxicological analysis. Toxicological assessment of the drug. To identify the circumstances of consumption that possibly enhance toxicity.
Brief summary in scientific language
Since 2008, there has been an increase in the consumption of designer drugs. Two thirds of the substances that were newly recorded by the european early warning system were synthetic cannabinoids and synthetic cathinones. Whereas in the past many of this substances were placed under illicit-drugs-laws (lastly in July 2012), some new substances have still have no legal regulation. These seemingly harmless products can therefore lead to unexpected psychic and physical disorder causing the 'user' to seek medical help in emergency units or consult a poison control center. In order to associate the reported symptoms to the consumed substances, an analytical proof of the named substances is required. Primary objective: To find out which new drugs lead to consultation of poison control centers and emergency units because of undesirable effects. To correlate symptoms and outcome to the substances found in the toxicological analysis. Toxicological assessment of the drug. To identify the circumstances of consumption that possibly enhance toxicity. Secondary objective: -To discover interaction with other drugs and medication. - To improve the quality of emergeny treatment and of emergency consultation
Health condition or problem studied
- Free text:
- Acute poisoning through new designer drugs
- ICD10:
- T40.7 - Cannabis (derivatives)
- ICD10:
- T43.9 - Psychotropic drug, unspecified
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Two Parts: Part 1: Retrospective inquiry in the poison control center Freiburg database, regarding cases of human exposure to new designer drugs (cathinone derivatives and other drugs not listed in the PCC- Freiburg till 2007), as well as ‘Spice’ mixtures which lead to consultation of medical facilities and emergency units. Correlation of this pseudomised data with analytical data of the forensic department. The specified period is between 02/2011- 04/2013 for ‘Spice’ mixtures and between 01/01/2008 - 30/04/2013 for other designer drugs. Part 2: prospective survey of acute intoxications by new synthetic designer drugs and other (unknown) drugs especially synthetic cannbinoids, cathinone derivatives and research chemicals, that were not listed in the PCC databank till 2007 Collected data Case number (pseudomised), Type of caller (hospital/emergency doctor, private practice), year of primary consultation, age (years), gender, weight, primary agent ( name of drug /chemical, dose (if known), other agents (substance, dose), time lapse, form and circumstances of exposure, mode (inhalative, oral), symptoms, outcome, recommended and performed diagnostics (including toxicological analysis), therapy ( duration of in- patient therapy in days) risks ( pre-existing conditions, other agents)- if known. Assessment of the Data and allocation of poisoning severity scores, PSS [Persson 1998]
Endpoints
- Primary outcome:
- Primary objective: To find out which new drugs lead to consultation of poison control centers and emergency units because of undesirable effects. To correlate symptoms and outcome to the substances found in the toxicological analysis. Toxicological assessment of the drug. To identify the circumstances of consumption that possibly enhance toxicity.
- Secondary outcome:
- Secondary objective: -To discover interaction with other drugs and medication. - To improve the quality of consultation during emergency
Study Design
- Purpose:
- Prevention
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Vergiftungs-Informations-Zentrale Freiburg im Breisgau
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2013-08-14
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 250
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- no minimum age
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- -Exposure to new synthetic Designer Drugs and other (unknown) drugs especially cathinone derivatives and Research chemicals that were not listed in the PCC Databank till 2007, as well as sythetic cannabinoids - Consultation of a medical/emergency Unit - Agreement to participation in Survey
Exclusion Criteria
- Non-professional inquiry - Disagreement to participation in Survey
Addresses
Primary Sponsor
- Address:
- Vergiftungs-Informations-Zentrale, Zentrum für Kinder- und Jugendmedizin, UniversitätsklinikumBreisacher Str. 86b79110 FreiburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.giftberatung.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Vergiftungs-Informations-ZentraleDr. med. Maren Hermanns-ClausenBreisacher Str. 86b79110 FreiburgGermany
- Telephone:
- + 49 761/19240
- Fax:
- + 49 761/270 44570
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.giftberatung.de
Contact for Public Queries
- Address:
- Vergiftungs-Informations-ZentraleUwe StedtlerBreisacher Str. 86b79110 FreiburgGermany
- Telephone:
- + 49 761/19240
- Fax:
- +49 761/270 44570
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.giftberatung.de
Principal Investigator
- Address:
- Vergiftungs-Informations-ZentraleDr. med. Maren Hermanns-ClausenBreisacher Str. 86b79110 FreiburgGermany
- Telephone:
- + 49 761/19240
- Fax:
- + 49 761/270 44570
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.giftberatung.de
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Bundesministerium für Gesundheit (BMG)Rochusstr. 153123 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- European Commission, Directorate-General for Research and InnovationORBN 2/65B-1049 BrusselsBelgium
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Albert-Ludwigs-Universität FreiburgEngelberger Str. 2179106 FreiburgGermany
- Telephone:
- +49-761-27072600
- Fax:
- +49-761-27072630
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2013-05-31
- Ethics committee number:
- 235/13
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2013-06-11
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- XXXIV International Congress of the European Association of Poisons Centres and Clinical Toxicologists (EAPCCT) 27–30 May 2014, Brussels, Belgium: 151. Acute intoxications by new psychoactive substances: Patterns of use and circumstances of exposure EU Project SPICE II Plus
- XXXV International Congress of the European Association of Poisons Centres and Clinical Toxicologists (EAPCCT) 26–29 May 2015, St Julian ’ s, Malta: 277. Bad trip due to 25I-NBOMe: A case report from the EU Project SPICE II Plus
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Akute Vergiftungen durch neue psychoaktive Drogen im Kindesalter: EU Project „SPICE II Plus“
- Hermanns-Clausen M et al: Acute toxicity due to the confirmed consumption of synthetic cannabinoids: clinical and laboratory findings.
- Hermanns-Clausen M et al: Acute intoxication by synthetic cannabinoids--four case reports.
- Adverse effects after the use of JWH-210 - a case series from the EU Spice II plus project.
- Müller D etal: Desoxypipradrol – eine neue (alte) Designerdroge
- Hermanns-Clausen M et al: Bad trip due to 25I-NBOMe: a case report from the EU project SPICE II plus.
- Franz F et al: Metabolites of synthetic cannabinoids in hair--proof of consumption or false friends for interpretation?
- Hermanns-Clausen M et al: Acute side effects after consumption of the new synthetic cannabinoids AB-CHMINACA and MDMB-CHMICA.
- Wilde M, Sommer MJ, Auwärter V, Hermanns-Clausen M. Acute severe intoxication with cyclopropylfentanyl, a novel synthetic opioid. Toxicol Lett. 2020 Mar 1;320:109-112.
- Grumann C, Henkel K, Stratford A, Hermanns-Clausen M, Passie T, Brandt SD, Auwärter V: Validation of an LC-MS/MS method for the quantitative analysis of 1P-LSD and its tentative metabolite LSD in fortified urine and serum samples including stability tests for 1P-LSD under different storage conditions. J Pharm Biomed Anal. 2019 Sep 10;174:270-276.
- Halter S, Angerer V, Röhrich J, Groth O, Roider G, Hermanns-Clausen M, Auwärter V: Cumyl-PEGACLONE: A comparatively safe new synthetic cannabinoid receptor agonist entering the NPS market? Drug Test Anal. 2019 Feb;11(2):347-349
- Sommer MJ, Halter S, Angerer V, Auwärter V, Eyer F, Liebetrau G, Ebbecke M, Hermanns-Clausen M: Effect of new legislation in Germany on prevalence and harm of synthetic cannabinoids. Clin Toxicol (Phila). 2022 Oct;60(10):1130-1138.
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry